Merck's ADC-Keytruda Combo Shows Promise in First-Line Lung Cancer Treatment

Merck & Co. and its partner Kelun-Biotech have reported a significant breakthrough in the treatment of non-small cell lung cancer (NSCLC), as their antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) combined with Keytruda demonstrated superior efficacy in a phase 3 trial.

Phase 3 Trial Success

The OptiTROP-Lung05 study, conducted in Chinese patients with previously untreated PD-L1-positive NSCLC, met its primary endpoint at an interim analysis. The combination of sac-TMT and Keytruda showed a "statistically significant and clinically meaningful" improvement in progression-free survival compared to Keytruda alone.

This marks the first time an ADC combined with an immune checkpoint inhibitor has achieved its primary endpoint in a phase 3 trial for first-line NSCLC treatment. Based on these results, Kelun-Biotech plans to engage with Chinese regulators regarding a potential approval application.

Expanding the ADC Landscape

The success of sac-TMT adds to the growing interest in ADCs for cancer treatment. Kelun-Biotech recently obtained approval in China for sac-TMT in second-line EGFR-mutant NSCLC, following strong phase 3 results in both progression-free survival and overall survival versus chemotherapy.

Merck is aggressively advancing sac-TMT's development, with 15 registered phase 3 trials and a recent $700 million royalty deal with Blackstone to support further research. The TroFuse-007 trial is currently evaluating the combination of sac-TMT and Keytruda against Keytruda alone in first-line PD-L1-high NSCLC patients.

Competitive Landscape and Future Outlook

The TROP2 ADC field is becoming increasingly competitive. Gilead Sciences' Trodelvy, the first-to-market TROP2 ADC, is awaiting results from the phase 3 Evoke-03 trial in second-line NSCLC. Meanwhile, AstraZeneca and Daiichi Sankyo's Datroway is being evaluated in the ambitious Avanzar trial, which aims to compare a combination of Imfinzi, Datroway, and chemotherapy against the current standard of Keytruda and chemotherapy in first-line NSCLC.

As these trials progress, the pharmaceutical industry eagerly anticipates further developments that could potentially reshape the treatment landscape for lung cancer patients.